BIS

GUDID 20884521134505

Quatro Sensor

Covidien LP

Single-patient intensive/general healthcare physiologic monitoring system Single-patient intensive/general healthcare physiologic monitoring system General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor Anaesthesia depth monitor

• Primary Device ID: 20884521134505
• NIH Device Record Key: 1ed1567d-f801-40de-b79b-3d0b4fa512c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIS
• Version Model Number: 186-0106-PH
• Company DUNS: 058614483
• Company Name: Covidien LP
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: Covidien.UDI@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Fragile; Keep dry; This side up
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884521134505 [Primary]
GS1	30884521134502 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072286
• Premarket Notification: K093183

FDA Product Code

• GXY: Electrode, Cutaneous
• OLW: Index-generating electroencephalograph software

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-10-20

On-Brand Devices [BIS]

• 90884521657515: Quatro Sensor Kit, (25) 186-0106
• 10884521657830: Extend Sensor
• 20884521134505: Quatro Sensor
• 10884521133884: 4 Electrode Sensor For use with BIS Monitoring Systems
• 10884521130111: BIS Module,Refurbished,For Philips Medical Monitors
• 90884521211267: Quatro Starter Kit, (1) 186-0106, (5) 186-0150-PH
• 90884521722961: SIMULATOR SENSOR
• 90884521548387: PHILIPS BILATERAL SENSOR KIT
• 10884521134546: Pediatric Starter Kit, (1) 186-0200, (5) 186-206
• 20884521134475: BILATERAL SENSOR
• 20884521134338: PEDIATRIC SENSOR
• 10884521134317: QUATRO STARTER KIT, (1) 186-0106, (5) 186-0150
• 10884521157545: A2000 Monitoring System,Refurbished
• 10884521128774: Digital Signal Converter, DSC-XP,Refurbished
• 10884521170247: BISX4 Module,Refurbished, Software Version 1.15,For use with BIS Monitors
• 10884521128859: Digital Signal Converter, DSC-XP,Refurbished,For Philips Medical Monitors
• 10884521129658: BISX Module,Software Version 1.13,For use with Mindray Patient Monitors
• 10884521533097: BISX4 Module Software Version 1.15
• 10884521533080: BISX4 Module
• 10884521533127: BISX Module
• 10884521812369: BISX4 Module Refurbished, Software Version 1.15; For use with Nihon Kohden Monitors
• 10884521533110: BISX Module
• 10884521533066: BISX4 Module
• 10884521533073: BISX4 Module Software Version 1.15; For use with Nihon Kohden Monitors
• 10884521134478: Bilateral Sensor For use with BIS Monitoring Systems
• 10884521702868: BIS LoC 2 Channel, Refurbished, Software Version 1.13 For use with Philips Patient Monitors
• 10884521702851: BIS LoC 2 Channel Refurbished, Software Version 1.13 For use with Philips Patient Monitors
• 10884521553170: BIS LoC 4 Channel Refurbished, Software Version 1.15. For use with Philips Patient Monitors
• 10884521553163: BISX4 Module
• 10884521186064: BISX Module,Refurbished, Software Version 1.13
• 10884521175501: OEM A2000 Simulator Demo,Refurbished
• 10884521170278: Monitoring System
• 10884521170261: Monitoring System
• 10884521170254: BISX4 Module,Refurbished, Software Version 1.15,For use with BIS Monitors
• 10884521170230: BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
• 10884521170223: BISX Module,Refurbished, Software Version 1.15,For use with BIS Monitors
• 10884521160231: BISX Module,Refurbished, Software Version 1.13
• 10884521157538: Monitoring System,Refurbished
• 10884521130265: BISX Module,Refurbished, Software Version 1.13
• 10884521130258: BISX Module,Refurbished, Software Version 1.13,For use with Philips Patient Monitors
• 10884521130234: BISX Module,Refurbished, Software Version 1.13
• 10884521130210: BISX Module Refurbished, Software Version 1.13
• 10884521130197: BISX4 Module,Software Version 1.13
• 10884521130180: BISX4 Module,Refurbished
• 10884521130173: Monitoring System,Refurbished
• 10884521130098: BISX Module,Software Version 1.13,For use with Philips Patient Monitors
• 10884521130074: BISX Module,Software Version 1.13,For use with Spacelabs Healthcare Patient Monitors
• 10884521129832: BISX Module,Software Version 1.15,For use with BIS Complete Monitors
• 10884521129825: BISX Module,Refurbished, Software Version 1.15
• 10884521129788: BISX Module,Software Version 1.13,For use with Nihon Kohden Patient Monitors